Development of New Formulations of Biologics: Expectations, Immunogenicity, and Safety for Subcutaneous Trastuzumab-Reference-Cited by-同舟云学术

Development of New Formulations of Biologics: Expectations, Immunogenicity, and Safety for Subcutaneous Trastuzumab

Published:2018-09-24 Issue:5 Volume:32 Page:319-325
ISSN:1178-2595
Container-title:Pharmaceutical Medicine
language:en
Short-container-title:Pharm Med

Author:

Pimentel Franklin Fernandes,Morgan Gilberto,Tiezzi Daniel Guimarães,de Andrade Jurandyr Moreira

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical),Pharmacology

Link

http://link.springer.com/article/10.1007/s40290-018-0247-5/fulltext.html

Reference53 articles.

1. Biologic License Application (BLA): 103792. Company: Genentech. Herceptin–trastuzumab. Drugs@FDA: FDA approved drug products. 2017. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=103792 . Accessed 22 Aug 2018.

2. Herceptin (trastuzumab). European Medicines Agency—Science Medicines Health. 2000. http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000278/WC500074922 . Accessed 22 Aug 2018.

3. Shulman LN, Torode J, Wagner C, Lopes GL Jr, Barr R, Magrini N. WHO expands cancer essential medicines list. ASCO Daily News. 2016. http://am.asco.org/daily-news/who-expands-cancer-essential-medicines-list . Accessed 22 Aug 2018.

4. Shulman LN, Wagner CM, Barr R, Lopes G, Longo G, Robertson J, et al. Proposing essential medicines to treat cancer: methodologies, processes, and outcomes. J Clin Oncol. 2016;34(1):69–75.

5. Vogel CL, Cobleigh MA, Tripathy D, Gutheil JC, Harris LN, Fehrenbacher L, et al. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol. 2002;20(3):719–26.

Cited by 13 articles. 订阅此论文施引文献订阅此论文施引文献，注册后可以免费订阅5篇论文的施引文献，订阅后可以查看论文全部施引文献

1. Pharmacokinetics, Safety, Tolerability, and Immunogenicity of BP02 (Trastuzumab Biosimilar) Compared to EU- and US-Approved Trastuzumab in Healthy Adult Male Volunteers: A Phase 1, Randomized, Double-Blind Study;Oncology and Therapy;2024-07-07

2. Efficacy and Safety of BP02 (Trastuzumab Biosimilar) in HER2-Positive Metastatic Breast Cancer: A Multicenter Phase III Study;Clinical Drug Investigation;2024-06-27

3. Biosimilars in Oncology: Latest Trends and Regulatory Status;Pharmaceutics;2022-12-05

4. Subcutaneous injection of trastuzumab into the thigh versus abdominal wall in patients with HER2-positive early breast cancer: Pharmacokinetic, safety and patients' preference - Substudy of the randomised phase III GAIN-2 study;The Breast;2022-12

5. Is weight-based IV dosing of trastuzumab preferable to SC fixed-dose in some patients? A systematic scoping review;The Breast;2021-06